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The ACUITY Break-Away™ Lead Delivery System is intended to access the coronary venous system and may be used alone (8F) or in dual catheter delivery (8F with 6F). The system serves as a conduit for the delivery of contrast medium and devices, including implantable coronary venous leads, introduced into the coronary venous system.

The ACUITY Break-Away™ Delivery System consists of two guide catheters plus the following accessories: torque device, guidewire introducer and cutter. The system is designed to provide venous access and to aid with the selective placement of implantable venous leads in the left cardiac vasculature. The catheters, provided in a 8F size and 6F size models, are packaged separately. The 8F catheter package also contains the torque device and guidewire introducer accessories, which assist with implanting the lead, and the cutter, which is used to facilitate removal of the catheters after implant. The 6F catheter is packaged alone. The 8F catheter may be used by itself or in conjunction with the 6F catheter in a telescoping manner to improve the access and delivery capabilities of the system. The ACUITY Break-Away catheter models feature a hub that is manually split apart rather than cut, and also incorporate a hemostasis valve to eliminate the need for an external accessory valve. The catheter is designed with a flexible distal segment and a soft tip to atraumatically enter the main coronary sinus and branch veins. The 6F ACUITY Break-Away catheter must be used with an 8F ACUITY Break-Away guide catheter to gain access to the main coronary sinus.

The provided text describes a 510(k) submission for the ACUITY Break-Away™ Delivery System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the input does not contain the information needed to answer the questions about acceptance criteria and a study proving a device meets them. The document explicitly states: "Summary of Clinical Testing: Clinical evaluation was not required."

The request asks for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Training set sample size.
9. Ground truth establishment for the training set.

None of this information is present in the provided 510(k) summary because a clinical study (which would generate such data) was not required for this device's regulatory pathway.

Instead, the document details a "Summary of Non-Clinical Testing" which involved:

• Design verification testing, including mechanical bench testing, animal testing, and heart modeling.
• Biocompatibility, packaging, and sterility testing.

These tests were conducted to verify that the performance of the ACUITY Break-Away catheters remains substantially equivalent to the predicate devices. The results confirmed that the modified catheters continue to meet all design and performance specifications and conform to relevant ISO standards (10993-1 for biocompatibility, 11137 for sterilization, and 11135 for EtO residual).

The basis for this 510(k) clearance is substantial equivalence, not a clinical study demonstrating specific performance metrics against hard acceptance criteria.

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The Boston Scientific ACUITY™ Universal Cutter is intended to be used with Guidant or Boston Scientific cuttable families of guiding catheters, and is intended to facilitate guiding catheter removal after the Guidant or Boston Scientific coronary venous lead is positioned.

The Cutter is an accessory manufactured for use with cuttable guiding catheters, to facilitate removal of the catheter following lead placement. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. The Cutter consists of three sections: a molded plastic handle, a stainless steel blade and a lead management section. The lead management section secures and stabilizes the lead prior to and during the cutting procedure. After the lead has been positioned in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the implanter pulls the catheter against the cutter blade. The hub is cut first, followed by the catheter section.

The provided text is a 510(k) submission for the ACUITY™ Universal Cutter, which is a medical device. This document does not describe a study that involves an AI algorithm or performance metrics like accuracy, sensitivity, or specificity commonly associated with AI models. Instead, it focuses on demonstrating substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of medical device submission.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format, nor does it provide specific quantitative performance metrics. Instead, it states:

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "testing" without detailing the specific methodology or dataset size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The device is a mechanical cutter, and its performance evaluation would typically involve functional testing (e.g., cutting efficacy, durability) rather than expert-established ground truth on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable. No expert adjudication method is mentioned or implied for the performance testing of this mechanical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device, and therefore, no MRMC study or AI-related effect size data would be present.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) does not directly apply here. For this device, the "ground truth" for its performance would be its ability to effectively and safely cut the guiding catheter as intended. This would be established through engineering and performance testing rather than clinical diagnostic ground truth.

8. The sample size for the training set

Not applicable. As a mechanical device, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this mechanical device.

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